Alembic Pharma gets USFDA nod for generic antidepressant drug
New Delhi : Alembic Pharmaceuticals has received approval from the US health regulator for generic Fluoxetine Hydrochloride tablets used for the treatment of depression and panic disorder.
The approval is for the generic version of Eli Lilly and Company's Prozac tablets in the same strengths, Alembic Pharma said in a BSE filing.
The tablets are indicated for treatment of major depressive disorder and obsessive compulsive disorder in adult and paediatric patients, it said.
They are also indicated for treatment of binge-eating and vomiting behaviour in moderate to severe Bulimia Nervosa and acute treatment of panic disorder, in adult patients.
"The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Fluoxetine Hydrochloride tablets, 10 mg and 20 mg", it said.
These tablets have an estimated market size of USD 120 million for 12 months ending December 2015 according to IMS, the company added.
Alembic Pharma currently has a total of 53 ANDA approvals from the US health regulator.
The company's stock was trading 0.84 per cent higher at Rs 625 per scrip on BSE.